QIR Suite is a software tool designed to help medical professionals analyze cardiovascular magnetic resonance images. It uses standard and deep learning algorithms to automate measurements like heart chamber function and blood flow, aiding diagnosis and treatment planning for adult patients with heart conditions.
Intended Use
For viewing, post-processing, and quantitative evaluation of cardiovascular Magnetic Resonance (MR) images in a DICOM Standard format, validated for adult patients.
Technology
Software uses user inputs, standard algorithms, and automated deep learning detection algorithms to perform visualization, segmentation, cardiac function analyses (ejection fraction, myocardial mass, thickness, diastolic function), 2D flow studies, and integrates with PACS and HL7 servers.
Performance
QIR Suite underwent extensive verification and validation including unit tests, software integration and verification tests, clinical evaluation by physicians. Performance was compared to predicate devices using patient MR datasets from multiple vendors and field strengths, showing high correlation (>0.97) and low mean differences (<10%) in quantitative measurements. Deep learning segmentation algorithms achieved Dice coefficients around 0.89 to 0.91, comparable to published results. No new clinical studies were required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/25/2021
1 year, 4 months - 2
FDA Approval
9/30/2022
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